Biomedical Ethics In Pharmacology An Introduction And Framework

The relationship between physicians, scientists, and the pharmaceutical industry is a mutually advantageous one that is fraught with ethical complexity. Seemingly straightforward questions, such as whether a physician ought to enroll patients in a drug trial, which drug to prescribe when any one of several may be effective, and how to stay abreast of new drugs while remaining objective, become difficult when examined closely. This chapter provides a conceptual framework for bioethical analysis, presents some cases that illustrate ethical problems, and delineates some guidelines for consideration.

Bioethics is the study of ethical issues associated with providing health care or pursuing biomedical research. Most approaches to bioethics in the United States are secular in nature and presuppose no particular religious or theological perspective. While one's religious beliefs may play an important role in determining personal morality, the broader endeavor of bioethical analysis attempts to be devoid of any particular religious perspective. Similarly, bioethical analysis stands independent of legal analysis. Although the law is often a consideration in bioethical decision making, laws in themselves do not determine the morality of an action. Laws are supposed to reflect a societal consensus on issues and are established to set a minimum standard of behavior.

Thus, while religion and law provide guidelines for acceptable actions, religious beliefs, and knowledge of the law are frequently insufficient to guide moral action, in the realm of health care. Solving problems that arise in the scientific and clinical contexts requires knowledge of ethical principles and the methodology for applying them. While bioethical analysis is multifac-torial, four moral principles play key roles in establish ing a basic framework. These principles were developed from a pluralistic, albeit North American, framework. Although not every problem will involve all four principles of bioethics, an understanding of the principles of autonomy, beneficence, nonmaleficence, and justice will build a solid framework for critical analysis.

The principle of autonomy entails that persons should be treated as inherently valuable individuals with the moral right to make decisions about their own lives. To the extent that one's actions and choices do not negatively affect others, individuals with the capacity to make their own decisions should be free to do as they wish, even if their choices are risky or harmful to themselves. The principle also entails that persons with diminished autonomy, such as those who are illiterate or retarded, deserve to have their interests protected. Many moral obligations for professionals engaged in scientific research or health care are derived from the principle of autonomy, such as the physician-researcher's obligation to fully inform potential research subjects and respect the individual's informed consent or informed refusal. This obligation is founded on the principle that individuals are the appropriate decision makers for choices that do not harm others.

The principle of beneficence entails helping people to further their interests. As the primary moral principle quoted in medical codes and oaths, the principle of beneficence is fundamental to the practice of medicine and clinical research. For example, concerns about beneficence motivate physicians, pharmacologists, pharmacists, and clinical investigators, all of whom share the goal of conducting studies that will ultimately benefit society by producing or refining effective treatments.

The principle of nonmaleficence asserts that professionals have an obligation to prevent harm or if harm is unavoidable, minimize that harm. This principle plays an important role in clinical research, as it entails an obligation to minimize risks to each participant. Moreover, drug approval procedures, such as those implemented by the Food and Drug Administration (FDA), are designed to protect patients from harm while ultimately facilitating the marketing of drugs that have maximal therapeutic benefits. Thus the principles of beneficence and non-maleficence dictate that the overall goal of scientific advancement cannot trump the duty to protect human subjects of clinical research from harm.

The principle of justice states that individuals should be given what they deserve, be that benefit or burden. Cases that are alike should be treated similarly, and relevant distinctions should be drawn consistently. The principle of justice does not specifically state what distinctions are fair or which criteria are reasonable; it simply requires that, once criteria are determined, they be applied fairly. Justice is important in many areas, such as recruitment of research subjects for pharmaceutical studies. For example, researchers must guard against distributing the burdens of participation disproportionately among populations that are poorly equipped to give informed consent, such as children or the mentally incompetent.

The principles of autonomy, beneficence, nonmalefi-cence, and justice form a foundation for analysis of ethical quandaries. In addition, a comprehensive ethical analysis will include considerations of cultural and religious diversity of patient-subjects, health care providers and interpersonal relationships; an assessment of the profession-based duties and obligations of the health care professionals, including an examination of relevant professional oaths and codes; and an analysis of relevantly similar previous bioethical dilemmas.

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